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Completed

NCT Number: NCT02926846

IV Antibiotics With Lavage for Severe PD Peritonitis

This is a randomized controlled trial to evaluate whether a switch to intravenous antibiotics with adjunctive lavage can improve the outcome of severe peritoneal dialysis related peritonitis.

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Key information

Conditions

Peritonitis Digestive System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Intraabdominal Infections Kidney Diseases Kidney Failure Male Urogenital Diseases Peritoneal Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Alice Ho Miu Ling Nethersole Hospital

Hong Kong

About this study

The standard treatment of peritoneal dialysis (PD) related peritonitis is intraperitoneal (IP) antibiotics. In severe cases not responding to the IP antibiotics treatment, timely Tenckhoff catheter removal is needed. There is no known adjunctive measure that can improve the clinical outcome of the patients suffering from severe PD peritonitis.

Based on the past experience in the investigators' center, switching IP to intravenous route of antibiotics administration, together with adjunctive lavage was proposed to improve the clinical outcome of severe PD peritonitis, in particular a possible improved catheter salvage rate. This method will be evaluated in the present clinical trial.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Prevalent PD patients with age >= 18 years old suffering from PD peritonitis
  • PD effluent white cell count >1090/mm2 on peritonitis day 3
  • Lack of clinical response
  • Informed consent available

Exclusion criteria

  • PD peritonitis in association with exit site or tunnel infection
  • Relapsing peritonitis (i.e. peritonitis caused by same organism within 4 weeks after completion of antibiotics therapy)
  • Fungal peritonitis
  • Mycobacterial peritonitis (both tuberculosis and non-tuberculosis species)
  • Clinical suspicion of surgical peritonitis
  • Penicillin- or cephalosporin allergy, that cefazolin and ceftazidime could not be used

Treatment and study plan

Intravenous vancomycin & gentamicin with adjunctive lavage

Drug

Intravenous vancomycin and gentamicin are administered, together with adjunctive lavage performed by automated peritoneal dialysis machine over 48 to 72 hours.

(choice of antibiotic is adjusted in accordance with the microbiology report when available)

Intraperitoneal vancomycin & gentamicin

Drug

Intraperitoneal vancomycin and gentamicin are administered, with the usual continuous ambulatory peritoneal dialysis schedule maintained.

(choice of antibiotic is adjusted in accordance with the microbiology report when available)

Primary outcomes

  1. Peritoneal dialysate effluent (PDE) white cell count and bacterial culture

    Time frame: PDE is monitored every 48 hours, until white cell count <100/mm3 and bacterial culture is negative; assessed up to 3 weeks

  2. Number of participants requiring Tenckhoff catheter removal

    Time frame: Tenckhoff catheter removal is arranged when there is no clinical response after 5 days of treatment

Secondary outcomes

  1. Number of participants developing relapsing peritonitis

    Time frame: All participants are observed for any peritonitis within 4 weeks of completion of antibiotics treatment

  2. Number of participants requiring hospitalization

    Time frame: All participants are observed for any hospitalization within 12 weeks of completion of antibiotics treatment

Sponsors and collaborators

Lead sponsor

Alice Ho Miu Ling Nethersole Hospital

Other

Registry information

Official study title

Randomized Trial on Intravenous Antibiotics With Adjunctive Lavage for Severe Peritoneal-dialysis Related Peritonitis

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Oct 6, 2016
Registry last updated
Jan 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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